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. 2021 May 6;2021(5):CD012972. doi: 10.1002/14651858.CD012972.pub2

Mupfumi 2014.

Study characteristics
Methods Single centre, pragmatic individually‐randomized controlled trial
Participants Participants included were consecutive symptomatic and asymptomatic HIV‐infected participants initiating anti‐retroviral therapy
18 years old and older
Female: 55%
HIV infection: 100% (HIV clinic)
Setting: specialized infectious disease hospital
Country: Zimbabwe
Sample size: 424
Interventions participants provided 2 spot sputum specimens at least 1 hour apart. If participants were unable to expectorate sputum, attempts were made to induce sputum using nebulized 6% hypertonic saline.
Samples in the microscopy group had a direct smear completed on each sample followed by staining with auramine O (Leica, Germany).
Xpert MTB/RIF assays were completed on direct sputum.
Outcomes Primary outcome: proportion of participants who were diagnosed with ART‐associated tuberculosis, or who died within 3 months of randomization
Notes Target condition: Tuberculosis
Case definition: participants with at least 1 positive Xpert or microscopy (for 'scanty' samples, both smears needed to be recorded as 'scanty')
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Allocation list was generated by the data manager and supplied to the laboratory manager in sealed envelope
Allocation concealment (selection bias) Low risk Allocation was given in sealed opaque envelope
Baseline characteristics similar (selection bias) Low risk Similar baseline characteristics in both groups
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding was not done. Blinding was not feasible given a pragmatic trial design, however, sample transporter to the central laboratory for quality control was blinded to participant identification
Protection against contamination (performance bias) Low risk Randomization was generated by a data manager, and codes were kept in envelopes; participants were assigned based on codes.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Blinding was not feasible; death occurring after tuberculosis diagnosis was considered tuberculosis‐related death, however, the authors did not clearly explain the different ways to verify death.
Incomplete outcome data (attrition bias)
All outcomes Low risk The proportion of loss to follow‐up was not significantly different between groups
Selective reporting (reporting bias) Low risk All outcomes in the methods were reported
Other bias Low risk Not detected